Clinical Trial Transparency: An IT Perspective By Vijai Krishna

Transcription

1 Clinical Trial Transparency: An IT Perspective By Vijai Krishna WHITEPAPER April 2015

2 TABLE OF CONTENTS INTRODUCTION 3 ROLE OF IT IN CLINICAL TRIAL TRANSPARENCY INITIATIVE (CTTI): AN INDUSTRY PERSPECTIVE 4 HCL S SOLUTION FOR CLINICAL TRIAL TRANSPARENCY 5 CONCLUSION 8 REFERENCES 8 HCL LIFE SCIENCES & HEALTHCARE 9 LET S CONNECT 9 ABOUT THE AUTHOR 9 ABOUT HCL , HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 2

3 INTRODUCTION Pharmaceutical companies compile large quantities of clinical research data, which, if shared more widely within and across sectors, could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and the conclusions derived from them by lending transparency to the clinical research process. For the good of society, this is a breakthrough that should be replicated throughout the research world. In 2014 the European Medicines Agency (EMA) was targeting new legislation Harlan M. Krumholz, professor of cardiology and public health, Yale School of Medicine requiring: 1. Adherence to trial data access requests. 2. Trial results disclosure on the EU Clinical Trials Registry. Pharmaceutical Research and Manufacturers of America (PhRMA), in association with European Federation of Pharmaceutical Industries and Associations (EFPIA), developed the guidelines for clinical trials data sharing. EFPIA and PhRMA have released some guiding principles around clinical trials data sharing including: y Enhancing data sharing with researchers while protecting patient confidentiality and commercially sensitive information y Enhancing public access to clinical study information y Sharing results with patients who participate in clinical trials y Certifying procedures for sharing clinical trial information y Reaffirming commitments to publish clinical trial results Institute of Medicine (IOM) also recommends sharing clinical research data with clinical research organizations, pharmaceutical industry and clinical trial volunteers. The announcement, made jointly by EFPIA and PhRMA in the United States and Europe, triggers a shift in the industry. The pharmaceutical industry in the past was resistant to share data systematically but based on the guidelines laid down by EFPIA and PhRMA they unanimously agreed to the new norms. These new norms are applicable to all new drugs/existing drugs, irrespective of country of approval (US or EU). Global major pharmaceutical companies covenanted to release detailed data about their drugs to outside researchers, this initiative has been appreciated by some but also seen as an effort to head off more extensive disclosure requirements that are under review in Europe. 2015, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 3

4 In sharing our data with worldwide researchers, we hope to further scientific research and increase understanding about our medicines. Our goal is to transition to a broader system allowing researchers to access data from trials conducted by multiple organizations. Senior Vice President for Science and Innovation, Top 10 Pharmaceutical Company ROLE OF IT IN CLINICAL TRIAL TRANSPARENCY INITIATIVE (CTTI): AN INDUSTRY PERSPECTIVE Clinical trials are becoming increasingly more complex and competitive for both clinical research organizations (CROs) and pharmaceutical companies. IT systems can help in the following ways: y Automate cross-study integration effort, lowering cost, and enhancing quality to derive value from existing data assets Identify potential new indications Enhance trial design Reduce number of trials conducted y Support and automate the aggregation and standardization of ongoing clinical trials y Provide prebuilt data models and processes to standardize data to CDISC SDTM y Automate migration of acquired data assets through data standards Stakeholders in CTTI The primary goal of the program is intended to provide capabilities listed below to two groups: y Investigators Redacted clinical study reports (CSR) can be accessed by investigators and not downloaded CSR request management request submission, review, approval, and CSR sharing Configurable workflows to support the CSR request management y Qualified external scientific and medical researchers Share clinical trial data with external researchers in a secured environment where analytical tools can be provided and used by researchers to perform statistical analysis. The data will be masked to protect personal data and commercially confidential information before sharing. 2015, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 4

5 HCL S SOLUTION FOR CLINICAL TRIAL TRANSPARENCY The clinical trials transparency initiatives proposed by EFPIA and PhRMA have unique implementation challenges which the pharmaceutical industry has not dealt with before. The desire to share data for collaborative research in clinical trials has to be balanced with the critical need to protect the privacy of patients and data integrity to protect IP of Pharma companies involved in the research. The negative impact of an accidental breach is so high from both a regulatory and business reputation prospective that the security and assurance of data protection and privacy necessitate a redundant security model and active mitigation procedures. This will ensure the highest level of data security while still allowing open access to nonprivate data to facilitate effective research. Our solution is in line with EFPIA and PhRMA guiding principles on clinical trials data sharing. NEW COLLABORATION PORTAL SOLUTION Technical architecture Potential Investigators Documents shared on the Client Collaborated portal Authenticate Module Initiated Document/ Data Offline process of document upload Data Document Investigator registers in portal Additional workflow to be defined for Data (Redacted CSR) Document Abstraction and management system Blinding Integration for Documents including CSR Extracted Data been Performance dashboard Web Analytics verified by Regulatory team before sharing Request sent to VM setup team Client firewall Data Abstraction and Blinding Manual process depending on data request from CDR, OMDB, PkPd VM machine setup Request sent to BI environment setup team (SAS/ Client Internal Environment R / Spotfire) BI tools setup Offline SAS / R / Spotfire process of Access granted to data upload user and provisioned to perform the detailed analysis Investigator performs the analysis Virtual Machine Surrendered The request logging and approval workflow is enumerated below: Approval Workflow Approvers 1 User submit CSR request 2 Request approval workflow runs and submitted request automatically routed to predefined approvers for approval. From portal page itself users would be able track the status of their request. 3 Once approved, user dynamically added to the relevant SharePoint groups and also automated mail send to the user. 4 User logged in to the secure portal and accordingly can see all the relevant requested documents. Users are allowed to read the documents but cannot take actions such as download a copy or modify the content of the documents 2015, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 5

6 y External users (such as investigator and researcher) submit a request in public SharePoint 2010 portal of client (available on cloud) for accessing study-related documents/trial data y A request form (will contain predefined criteria based on which users can request study-related documents/trial data) will be presented to users. Users will fill up the request form and accordingly will submit the same for further approval. y Upon submission of the request form, a configurable approval workflow would be invoked and accordingly submitted request will be automatically routed to a predefined path for approval. This path will be configurable and an administrator can change this route as and when required. y Once the request is fully approved, user s request information-related metadata and preference will be stored in a list and also user would be dynamically added to the relevant SharePoint groups and relevant permission would be given accordingly. Also an automated mail would be sent to the user containing the access link of secured collaboration portal page where user would be able to view all the requested documents. y After logging on to the secured portal, the user will be able to view all the relevant documents/links of the study which he/she had requested for. Information rights management can be used on lists or libraries to limit the dissemination of sensitive content. Information rights management can be enforced to limit the rights of the users who are allowed to read files but cannot take actions such as print copies of the files or cannot copy/modify the content. Also if required, using some simple script download a copy option can be hidden/disabled as well. Authentication Process (Security Model) Based on client s established way of authenticating investigators into client system/ portals, HCL would configure the required approach to leverage the defined system well (for authentication). All users (external and internal) will be brought in the system. HCL plans to use the same service, and provide authorized access only if certified by review panel, by using client authorized gateway. The access is provided based on various roles and permissions as defined by the client. Document sharing Documents, including redacted CSRs, to be shared are been picked from document management system (DMS), which in turn is linked to upstream applications and other integrations. Before the documents are shared, review panel would review the request and authorize as appropriate. Data sharing Once the data sharing request is approved, an additional workflow for data sharing will be developed. y The case will be raised for data extraction and blinding of sensitive data y The extracted data will again be verified by review panel 2015, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 6

7 y Review panel will also ensure that the data to be shared is regulatory compliant and no sensitive information is been passed over y On approval the data set will be sent to Virtual Machine(VM) team to setup VM and copy this data over the VM y Case will also be raised for business intelligence setup team to configure BI environment for the end user to do the analysis of data been copied over y After BI setup is complete, the user is completely provisioned and login credentials with VM address link details are shared with user on the sharepoint portal and through an message y As user logs in to the VM machine, he/she will be directed to the BI environment, where he/she can browse the data, message the same as required for his own analysis y After the analysis is complete, user logs off the BI tool, he will also be logged off out of virtual machine y The user will not be able to copy the data or download it by any means SOLUTION COMPONENTS y Data sharing, collaboration, and exchange platform for multiple pharmaceutical companies and researchers y Redacting capability for documents with PPD (protection of personal data) and CCI (commercially confidential information) y End-to-end management of data requests for submission, review and approval, agreement review and approval, data preparation and release, request amendment, data analysis, project initialization and closure, and monitoring y Robust and configurable workflows to support the end-to-end management of data requests y Robust compliance check of completeness for information submitted by requestors y Data are shared and not transferred to researchers; client retains control of data while analysis can be performed by recipient in the platform y Flexible platform to support multiple data analytic tools (e.g., SAS, R, graphical software, etc.) y Support for a variety of file types (doc, pdf, sas datasets, text files, csv files, etc.) y Track, report, and search meta-data of all data analysis activities. Report includes a dashboard of all the data requests, their status and researchers y Data are stored, backed-up, and versioned y A flexible access control model that supports multiple roles and permission management down to file level y A 21 CFR part 11 compliant solution that also tracks and displays audit trail y Cloud-based platform isolated from pharmaceutical companies internal systems 2015, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 7

8 y Secure gateway and connections for fetching data from document repositories, data stores for each member pharmaceutical company who would be part of this portal solution y Federated local data store containing private data for each member pharmaceutical company CONCLUSION Clinical trial data transparency enables qualified researchers to verify clinical trial results, improve the efficiency of clinical trials and advance medical knowledge. In addition, data sharing has the potential to improve public health, while also increasing public trust in clinical research and the life sciences industry. REFERENCES Responsible-Clinical-Trial-Data-Sharing-Become-Effective-Today Forms/PDF/SAS_RethinkingCTD.pdf 2015, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 8

9 HCL LIFE SCIENCES & HEALTHCARE HCL is a leading provider of Life Sciences and Healthcare Business and Technology services. We are the chosen service provider for enabling new growth drivers for our clients, providing them with industry leading best practices, taking care of their compliance needs and ensuring goldstandard process cycle times. Our clientele includes seven of the top ten global pharmaceutical companies, seven of the top ten medical devices companies, six of the top ten health plans, three of the top five CRO s and two of the top three data providers. Equipped with certified technology experts and domain specialists, HCL offers services in critical areas of the life sciences and healthcare eco system such as drug discovery, clinical development, drug safety, regulatory compliance, manufacturing and plant automation, commercial, Healthcare analytics, Population Health Management [PHM], mhealth, member experience management [MEM], fraud, waste and abuse management [FWA]. LET S CONNECT Please feel free to write to us at contact.lsh@hcl.com ABOUT THE AUTHOR Vijai Krishna joined HCL in June He has more than 10 years experience including more than 5 years experience in Pharma R&D IT especially in ectd, SPL, DMS and Oracle suite of life sciences products. He started his career as a professional sales representative for Fulford India (an affiliate of Schering Plough) before moving to Life Sciences IT product sales in the capacity of business development manager handling sales for the entire South India. In HCL, He is a part of the life sciences business solution group. He is responsible for analyzing and identifying white spaces to building business propositions in pharma R&D space. He holds a Bachelors Degree in Pharmacy, P.G. Diploma in Bioinformatics and P.G. Diploma in Marketing Management. 2015, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 9

10 ABOUT HCL About HCL Technologies HCL Technologies is a leading global IT services company working with clients in the areas that impact and redefine the core of their businesses. Since its emergence on the global landscape, and after its IPO in 1999, HCL has focused on transformational outsourcing, underlined by innovation and value creation, offering an integrated portfolio of services including software-led IT solutions, remote infrastructure management, engineering and R&D services and business services. HCL leverages its extensive global offshore infrastructure and network of offices in 31 countries to provide holistic, multi-service delivery in key industry verticals including Financial Services, Manufacturing, Consumer Services, Public Services and Healthcare & Life sciences. HCL takes pride in its philosophy of Employees First, Customers Second which empowers its 100,240 transformers to create real value for customers. HCL Technologies, along with its subsidiaries, had consolidated revenues of US$ 5.7 billion, for the Financial Year ended as on 31 st December 2014 (on LTM basis). For more information, please visit About HCL Enterprise HCL is a $6.8 billion leading global technology and IT enterprise comprising two companies listed in India HCL Technologies and HCL Infosystems. Founded in 1976, HCL is one of India s original IT garage start-ups. A pioneer of modern computing, HCL is a global transformational enterprise today. Its range of offerings includes product engineering, custom & package applications, BPO, IT infrastructure services, IT hardware, systems integration, and distribution of information and communications technology (ICT) products across a wide range of focused industry verticals. The HCL team consists of over 105,699 professionals of diverse nationalities, who operate from 31 countries including over 505 points of presence in India. HCL has partnerships with several leading global 1000 firms, including leading IT and technology firms. For more information, please visit Hello there! I am an Ideapreneur. I believe that sustainable business outcomes are driven by relationships nurtured through values like trust, transparency and flexibility. I respect the contract, but believe in going beyond through collaboration, applied innovation and new generation partnership models that put your interest above everything else. Right now 105,000 Ideapreneurs are in a Relationship Beyond the Contract with 500 customers in 31 countries. How can I help you?